Test Catheter Pilot Study in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Discomfort
研究概览
简要总结
The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Signed informed consent
- •Negative urine multistix
排除标准
- •Abnormalities, diseases or surgical procedures performed in the lower urinary tract
研究组 & 干预措施
Group A
SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2
干预措施: SpeediCath Compact Male (Device)
Group A
SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2
干预措施: Speedicath (Device)
Group B
SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2
干预措施: SpeediCath Compact Male (Device)
Group B
SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2
干预措施: Speedicath (Device)
结局指标
主要结局
Discomfort
时间窗: After each catheterisation
Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)
次要结局
- Handling(After each catheterisation)
- Preference(At study termination)
- Haematuria(After each catheterisation)